Duns Number:117458512
Device Description: The MGB Alert Internal Control Set MS2-E consists of reagents intended for use as an unass The MGB Alert Internal Control Set MS2-E consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set MS2-E can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Catalog Number
800365
Brand Name
MGB Alert Internal Control Set MS2-E
Version/Model Number
800365
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OLD
Product Code Name
Internal Polymerase Chain Reaction Control, Not Assay Specific
Public Device Record Key
164a96ec-1471-49f6-9597-9c53fd450a41
Public Version Date
October 15, 2020
Public Version Number
2
DI Record Publish Date
September 15, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 106 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |